GCP-RMA

Good Clinical Practice Records Managers Association
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From time to time the Association develops and publishes position papers and best practice standards. Some of these have been published in relevant trade and professional journals whilst others have been made available informally via the Association and affiliated websites.
 
NEW:
Relevant Communications Guidance Document

This document is intended to supplement the ICH Guideline for Good Clinical Practice section 8.3.11 “Relevant Communications Other Than Site Visits”. 2. In particular, it provides guidance on how to decide whether a communication is ‘relevant’ or not. Click HERE to download.

Records Retention Requirements for CROs and Central Laboratories [Originally published in Good Clinical Practice Journal 5, 1, 28-29pp, Jan/Feb 1998]

The record retention requirements for a clinical trial investigator and the trial sponsor are clearly specified in ICH GCP and various guidelines and Directives. However, the requirements for CROs and for central laboratories is not so clear. This paper explains how CROs and central labs determine which records they need to retain to comply with GCP.
 
Reconciliation of Used and Unused CRF Pages

For many years, the trial sponsor has retained unused CRF pages within the trial master file in order to demonstrate to an inspector that they truly were unused. This paper proposes a methodology that permits the sponsor to destroy unused pages yet retain the accountability for all pages that is required to comply with GCP.
 
 
Retention of Clinical Trial Records, Medical Records and Essential Documents: Will the Implementation of the GCP CT Directive Help to Harmonize this Process? [Originally published in Clinical Researcher 2, 8, 2-6pp, August 2002]

This paper outlines the discrepancies between the main regulations governing the management of trial documents and medical records, and discusses the potential impact on new regulations.
 
Guidelines for the Retention of Records at Investigator Sites [Originally published in Good Clinical Practice Journal 2, 6, 14-17pp, Dec 1995/Jan 1996]

Best practice and practical guidelines have been established over the years for the retention of records within the pharmaceutical industry. However, typically, the investigator site receives little training and guidance in this area and has minimal budget to spend on records retention. This paper provides essential guidance for the investigator.
 
Association Response to EU Commission Regarding Draft Directive on TMF, July 2004

During the review period for the TMF guidelines to support Directive 2001/20/EC (ENTR/F/2), the Commission decided to issue guidance as a new Directive. The draft was release for comment in July 2004. The Association provided a formal response to the Commission.
 
Association Response to EU Commission Regarding Draft EU Guidelines on TMF (ENTR/F/2 D), September 2002

Following the release of draft guidelines for managing trial records, in support of Directive 2001/20/EC, the Association made a formal response to the EU Commissioner providing feedback and recommendations for changes to the text.